I didn't see ambulatory ECG or ECG devices as such mentioned in the list. I'm not sure now if im looking at the right list. can some one please share the list. Also if the MDis not in list what is the process?

Dear Noorain
As of now only 15 devices are listed and they are all Class D devices, most of them are Catheters and the like.
We expect the list to be expanded to all the remaining Class D and Class C devices only by middle of 2018 with 6 months period for compliance.
So as of now ECG devices are not in the list
Sriram